Stable High-Yield Expression in CHO Cells – Your ISO 13485 & IVDR Partner
When high-quality glycosylation and regulatory compliance are non-negotiable, CHO cells are the industry gold standard. We offer comprehensive Cell Line Development (CLD) services to generate stable, high-yield producers for your recombinant proteins and antibodies. Designed for IVDR compliance and high process consistency, our CHO platform ensures scalable manufacturing in our ISO 13485-certified non-GMP facility with full documentation – ideal for diagnostic assays and preclinical therapeutic research requiring human-like post-translational modifications.
Developing Stable, High-Yield Cell Lines for Diagnostic Use
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Verified Monoclonality: “Regulatory bodies demand proof. We ensure high-probability monoclonality using state-of-the-art limiting dilution techniques, providing the documentation needed for your Master Cell Bank (MCB).”
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Mammalian Glycosylation: “Crucial for efficacy and safety. Our CHO platform delivers authentic mammalian post-translational modifications (PTMs), ensuring your antibodies and proteins behave exactly as intended in biological systems.”
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Process Stability & Scalability: “A cell line must perform from the flask to the bioreactor. We select clones not just for peak titer, but for genetic stability over generations, ensuring consistent product quality during scale-up.”
Your Benefits with Our CHO Expression Services
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High-Titer Expression – Identification of top-performing clones for cost-efficient manufacturing.
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ISO 13485 & IVDR Ready – Full traceability and documentation supporting your regulatory filings and clinical studies.
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Speed to Stable Pool – Rapid generation of stable pools for material generation while the final clonal cell line is being developed.
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Animal-Component-Free – We use chemically defined, serum-free media to minimize contamination risks and regulatory hurdles.
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Customized Screening – Tailored selection strategies to find the clone that best matches your specific product quality attributes (PQAs).
Ready to Start Your CHO Project? – Contact Us Now!
Do you need stable cell lines or complex recombinant proteins for your diagnostic or pre-clinical applications? Get in touch with us. Our experienced team will guide you through the entire Cell Line Development (CLD) process and develop a high-yield solution – robust, scalable, and compliant with ISO 13485 standards.
Are you specifically looking for recombinant antibody expression in CHO cells? Then visit our specialized service page.
Need rapid prototypes or microbial expression instead? Check our HEK or E. coli services.
Our CHO Expression Platform at a Glance
Technical Specifications & Capabilities
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Host Cell Lines – CHO (Chinese Hamster Ovary) suspension cells (cultivated in serum-free, chemically defined media)
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Vector Systems – High-level expression vectors optimized for stability and maximum protein secretion
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Selection Methods – Stringent metabolic or antibiotic selection strategies to ensure genetic stability
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Production Scale – Scalable processes from small-scale screening to pilot bioreactor production
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Quality Control (QC) – CGE, SDS-PAGE, SEC, protein concentration, Endotoxin and bioactivity testing on request
FAQ – Frequently Asked Questions about CHO Cell Line Development
Why choose stable CHO over transient expression?
Stable CHO cell lines are the regulatory gold standard for therapeutic and diagnostic proteins. They ensure batch-to-batch consistency, defined glycosylation patterns, and scalability for long-term manufacturing – essential for IVDR compliance and clinical applications.
How long does the Cell Line Development (CLD) process take?
A typical CLD project – from gene synthesis to a characterized research cell bank (RCB) – takes approximately 12 to 14 months. This includes transfection, selection, single-cell cloning (monoclonality), and stability testing. For faster material, we can generate “stable pools” in a few months.
Who owns the Intellectual Property (IP)?
We operate on a Fee-for-Service (FFS) basis. You retain full ownership of the Intellectual Property (IP) related to your specific target molecule and the project results. We do not claim royalties or downstream licensing fees.
What yields can be achieved?
Yields depend heavily on the specific protein. However, our optimized platform aims for high-titer production, typically reaching the gram-per-liter (g/L) range in fed-batch processes. We screen hundreds of clones to find the highest producers.
Do you support project planning and vector design?
Yes, our CHO expression services start at the DNA level. We assist with codon optimization, vector design, and cloning strategies to ensure maximum yields in your CHO-based projects.
